|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Light Sciences LLC |
|---|---|
| Information provided by: | Light Sciences LLC |
| ClinicalTrials.gov Identifier: | NCT00068068 |
Purpose
The purpose of this study is to determine whether the Litx platform is safe and effective in the treatment of liver metastasis arising from colorectal cancer. Litx is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Metastasis Colorectal Neoplasms Liver Neoplasms Neoplasm Metastasis |
Drug: Talaporfin sodium (LS11) Device: LED-based light infusion device Device: Light emitting diodes (LED) Procedure: Photodynamic therapy Procedure: Phototherapy Procedure: Chemotherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Treating Refractory Cancers With the Litx™ System: Phase II Safety and Efficacy Study in Patients With Liver Metastases From Colorectal Cancer That Have Failed Chemotherapy |
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2003 |
Patients that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or ultrasound guided percutaneous placement of a single, two, three, or four light infusion devices depending on their tumor characteristics. No more than 4 light sources will be used at a single treatment. The light infusion devices may be used in a single lesion or in multiple lesions.
Following radiographic confirmation of light infusion device placement, patients will receive an intravenous dose of LS11 at 40 mg/m². One hour following completion of LS11 administration, delivery of 200 J/cm light energy will begin. The light infusion device will then be manually removed and the patients will be observed for acute complication of light infusion device removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and be maintained as defined throughout the study period. On day 30+5 the patient will undergo clinical assessment and the tumor mass will be imaged using contrast enhanced spiral CT for determination of volume and radius of the tumor size, as well as tumor necrosis. The patient may then receive 5-FU and/or leucovorin + either irinotecan or oxaliplatin standard chemotherapy at day 30 visit. All patients, with or without chemotherapy at day 30, will undergo final clinical assessment and final tumor imaging evaluation using contrast CT at day 60+5 of Litx treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Patients must be excluded if any of the following apply:
Contacts and Locations| United States, Colorado | |
| HealthOne Alliance/Presbyterian St. Lukes Medical Center | |
| Denver, Colorado, United States, 80218 | |
| United States, North Carolina | |
| Eastern Carolina University, School of Medicine | |
| Greenville, North Carolina, United States, 27858 | |
| United States, Pennsylvania | |
| University of Pennsylvania / Department of Radiation Oncology | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Germany | |
| University Hospital Frankfurt, Johann Wolfgang Goethe-University | |
| Frankfurt am Main, Germany, D-60596 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00068068 History of Changes |
| Obsolete Identifiers: | NCT00078871 |
| Other Study ID Numbers: | LSC-OL002 |
| Study First Received: | September 4, 2003 |
| Last Updated: | September 18, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Photodynamic therapy Liver metastases Colorectal cancer Litx™ Light Infusion Technology™ Talaporfin sodium |
LS11 Liver mets Metastatic colorectal cancer Light emittting diodes (LED) Tumor ablation Combination therapy |
|
Neoplasms Colorectal Neoplasms Liver Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Liver Diseases Neoplastic Processes Pathologic Processes Talaporfin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |